A Safety And Efficacy Study Of HLA-G- Targeted CAR-T Cells IVS-3001 In Subjects With Previously Treated Advanced HLA-G-Positive Solid Tumors

Solid Tumor Clinical Trial

Official title: A Phase 1/2a, Safety And Efficacy Study Of HLA-G- Targeted CAR-T Cells IVS-3001 In Subjects With Previously Treated Advanced HLA-G-Positive Solid Tumors

Status Recruiting

Clinical Trial Summary

The proposed clinical study is a Phase 1/2a trial to investigate the safety, tolerability, pharmacokinetics and clinical activity of anti-HLA-G CAR-T cells IVS-3001 administered to subjects with previously treated, locally advanced, or metastatic solid tumors which are HLA-G positive (HLA-G+) - as determined by immunohistochemistry (IHC) analysis on tumor biopsies using the 4H84 antibody.

Clinical Trial Description

Primary Objectives:

IVS-3001 is an autologous CAR-T cell therapy targeting human leukocyte antigen (HLA-G)

• Phase 1: To determine the safety, tolerability and the recommended phase 2 dose (RP2D) of IVS-3001 in subjects with refractory or relapsed HLA-G+ solid tumors.

• Phase 2a: To evaluate the anti-tumor activity of IVS-3001 in selected HLA-G+ solid tumor types.

Secondary Objectives:

• To evaluate pharmacokinetic profile of IVS-3001: persistence, expansion.

• To evaluate the clinical activity of IVS-3001 in selected HLA-G+ solid tumor types.

• To assess the long-term safety of IVS-3001.

Exploratory Objectives:

• To explore functionality of IVS-3001 as well as immune biomarkers linked with IVS-3001 and their relationship with clinical response ;

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

• NCT number: NCT05672459
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Contact: Aung Naing, MD
• Phone: 713-563-3885
• Email: anaing@mdanderson.org
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 21, 2023
• Completion date: December 29, 2029